Objectives of the Enhanced Medical Device Procurement Strategy
The objectives of the enhanced procurement strategy are as follows:

1. To enhance the protection of public health
2. To ensure the safety, quality and performance of the medical devices procured by DH and the availability of after-sale (post-market) support from suppliers
3. To further promote and enhance understanding of the public, users and the industry on the Medical Device Administrative Control System (MDACS), with a view to having more MDs listed under MDACS (Listed MDs) to facilitate a smoother transition to the statutory system

Implementation Timeline of the Enhanced Procurement Strategy
As previously announced by DH, the enhanced measures of the new strategy are as follows:

1. Stage A – first phase of new strategy on procurement of medical devices (effective from 21st June 2023)
2. Stage B – second phase Stage 1 of new strategy on procurement of medical devices (effective from 1st November 2024)
3. Stage C – second phase Stage 2 of new strategy on procurement of medical devices (effective from 23rd March 2026)

Mandatory MDACS Listing Requirements under Stage C Implementation

Upon Implementation of Stage C, the essential requirement will be further elevated, mandating all applicable MDs (AMDs), refer to Class II/III/IV general medical devices (GMDs) and Class B/C/D in vitro diagnostic medical devices (IVDMDs) according to the classification rules under MDACS, procured by DH must be listed under MDACS.

Supplier must provide the following documentary evidence demonstrate compliance:

1. Copy of valid certificate of Listing with HKMD listing number (the listing shall be valid on the quotation / tender closing date)

Guidelines for Medical Device Listing Applications under MDACS

1. Traders are encouraged to submit applications for their AMDs to be listed under MDACS as soon as possible.
2. For application for listing of MDs, please refer to MDD website Listing application
3. The vetting and approval of an application for listing a device would normally be completed within 12 weeks (about 3 months) following the submission of the application and all the required supporting information, including labelling samples. (ref.: Guidance Notes GN-01)
4. To facilitate traders and public users to determine if a product is an MD, and if so, its associated class under MDACS, on-line tools have been developed on MDD website:

• Examples of Medical Devices Classification
• Examples of In Vitro Diagnostic Medical Device Classification
• Is Your Product a Medical Device?
• General Medical Device Classification Program
• In Vitro Diagnostic Medical Device Classification Program

Details on application for inclusion in the supplier list of the Government can be referred to the following updated links:

• Application for Inclusion in the DH Notification Lists
• Application for Inclusion in the GLD Notification Lists

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References

1. New Procurement Requirement
2. Enhanced Measures on Procurement of Medical Devices by the DH